Validation & Laboratory Services Specialist

3 giorni fa

Guidonia Montecelio, Lazio, Italia Merck KGaA A tempo pieno

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

You are:

Within the Validation & Lab Service engineering group, which is responsible for managing validation, maintenance, and calibration activities of utilities & laboratory equipment and the qualification of computerized systems, you will be involved in:

  • Collaborating in the drafting/review of documents (e.g., Validation Plan, Risk Analysis, Traceability Matrices, System Description) and qualification protocols for Computer Systems and/or Equipment;
  • Collaborating, reviewing, and/or executing tests for the validation of Computer Systems in accordance with internal procedures and the requirements of 21 CFR part 11 and/or Annex 11;
  • Drafting and/or issuing Validation Summary Reports and/or qualification reports;
  • Reviewing protocols and reports for validation, calibration, and maintenance;
  • Updating and maintaining the risk analysis;
  • Ensuring compliance with the requirements imposed for departments operating in controlled environments in accordance with GMP regulations;
  • Ensuring the drafting and updating of SOPs related to the belonging group;
  • Performing all necessary operations to ensure calibration, validation, and maintenance of laboratory equipment within the timeframes and methods stipulated by current GxP procedures
  • Promoting, as far as possible, activities related to "ISO" certifications, ensuring compliance with constraints/references.

Who you are:

  • One to three years of experience in managing and producing documents (protocols and reports) on validation and calibration activities for instruments and computerized systems;
  • Good knowledge of SAP (calibration, maintenance, and validation modules);
  • Excellent written and spoken knowledge of English and Italian;
  • Excellent knowledge of the Office suite and use of Project;
  • Excellent knowledge of GMP;
  • Excellent knowledge of the requirements of 21 CFR part 11 and/or Annex 11 for CS in GMP contexts;
  • Good presentation skills during inspections;
  • Strong teamwork orientation;

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity

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